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NCT Number: NCT02851186

Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases

Objectives:

To examine the efficacy and safety of electroacupuncture (EA) combined with auricular acupuncture (AA) in reducing post-operative pain in patients following abdominal surgery for gynecological diseases.

Hypothesis:

Acupuncture is effective and safe to reduce postoperative pain during the first 5 days following surgery as compared to a sham control.

Design and strategy:

This is a randomized, placebo-controlled, subject- and assessor-blind trial. Seventy-two subjects will be recruited and randomized (in 1:1 ratio) to receive either acupuncture treatment or sham control. Subjects in both groups will undergo standard operation procedure and receive post-operative analgesics based on usual care.

Study instrument:

A 10-point pain Numerical Rating Scale (NRS) will be employed as a primary outcome assessment.

Intervention:

Subjects in the treatment group will receive EA combined with AA within two hours before operation, post-operation upon arrival to the ward and once a day for the subsequent 5 days. Subjects in the control group will receive non-invasive sham procedure in the same schedule.

Main outcome measures:

Primary outcome: NRS pain scores will be measured upon recovery, hourly at 6 hours after surgery, then 4-hourly until day 2, 6-hourly until day 3 and once daily until discharge.

Secondary outcome:

Morphine consumption, post-operative syndromes, quality of recovery questionnaire, SF-6D, EQ-5D-5L and adverse events will be documented and compared between groups.

Data analysis: Pain intensity during the first 5 days will be calculated by Area Under the Curve (AUC) of NRS pain scores. AUC between the two groups will be compared by Student's T-test.

Expected outcome: AUC of the acupuncture group is expected to be significantly lower than sham acupuncture group.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I to III
  • Eligible for laparotomy with midline incision for gynaecological neoplasm including ovarian mass, uterine mass and cervical lesions
  • Age 18 years or above
  • Ability to understand the nature of the study and willing to give informed consent
  • Capable of providing responses during outcome measurement

Exclusion criteria

  • Having chronic pain and using any medication in addition to the anaesthetic and analgesia prescribed prior to surgery that would be expected to affect the dosage of postoperative analgesia
  • History of or current alcohol or drug abuse
  • Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
  • Impaired hepatic function, defined as preoperative serum albumin level below 30g/L
  • Impaired or retarded mental state and not able to sign the consent
  • Not self-ambulatory before operation
  • Difficulties in using patient-controlled analgesia
  • BMI > 35kg/m2
  • Infection observed at the acupoint sites
  • History of acupuncture experience in the previous 12 months
  • History or clinical evidence of valvular heart defects, heart failure, atrial fibrillation or bleeding disorders or are fitted with cardiac pacemaker or taking anticoagulant drugs

Treatment and study plan

acupuncture

Device

Sham acupuncture

Device

Primary outcomes

  1. Area under the curve of Pain intensity by numerical rating scale (NRS) from baseline to day 5

    Time frame: 5 days

Secondary outcomes

  1. Pain intensity by numerical rating scale (NRS) at rest

    Time frame: Through study completion, an average of 7 days

  2. Pain intensity by numerical rating scale (NRS) while coughing

    Time frame: Through study completion, an average of 7 days

  3. Cumulative morphine consumption

    Time frame: Through study completion, an average of 7 days

  4. Dose of rescues analgesic (IM morphine) use

    Time frame: Through study completion, an average of 7 days

  5. Frequency of rescues analgesic (IM morphine) use

    Time frame: Through study completion, an average of 7 days

  6. Time of recovery from postoperative syndrome

    Time frame: Through study completion, an average of 7 days

  7. Quality of recovery (QoR-9)

    Time frame: Through study completion, an average of 7 days

  8. SF-6D

    Time frame: Through study completion, an average of 7 days

  9. EQ-5D-5L

    Time frame: Through study completion, an average of 7 days

Other outcomes

  1. Number of patients withdraw

    Time frame: Through study completion, an average of 7 days

  2. Reasons of withdrawal

    Time frame: Through study completion, an average of 7 days

  3. Number of subjects with adverse events

    Time frame: Through study completion, an average of 7 days

  4. Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)

    Time frame: Through study completion, an average of 7 days

  5. Blinding Success Assessment by questionnaire

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Combined Electroacupuncture and Auricular Acupuncture for Postoperative Pain After Abdominal Surgery for Gynecological Diseases: A Randomized Sham-controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2016
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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